| CTRI Number |
CTRI/2023/07/055001 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
LAVANA POTTALI SWEDA AND VALUKA POTTALI SWEDA IN AMAVATAJANYA SHOTHADI LAKSHANA W.S.R TO RHEUMATOID ARTHRITIS |
|
Scientific Title of Study
|
AN OPEN LABELLED RANDOMIZED COMPARATIVE CLINICAL TRIAL OF LAVANA POTTALI SWEDA AND VALUKA POTTALI SWEDA IN AMAVATAJANYA SHOTHADI LAKSHANA W.S.R TO RHEUMATOID ARTHRITIS |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Romana Barodiya |
| Designation |
PG Scholar |
| Affiliation |
Government Akhandanand Ayurveda college |
| Address |
OPD NO.5 Department of panchakarma, Government Akhandanand Ayurveda Collage and Hospital, Bhadra.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9978667431 |
| Fax |
|
| Email |
romanabarodiya786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Falgun P patel |
| Designation |
M.D.(Ayu), Panchakarma specialist, Reader, Deputy Director of Training & Research, AYUSH, Gujrat |
| Affiliation |
Government Akhandanand Ayurveda college |
| Address |
OPD NO.5 Department of panchakarma, Government Akhandanand Ayurveda Collage and Hospital, Bhadra.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9426404004 |
| Fax |
|
| Email |
vd.falgun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Falgun P patel |
| Designation |
M.D.(Ayu), Panchakarma specialist, Reader, Deputy Director of Training & Research, AYUSH, Gujrat |
| Affiliation |
Government Akhandanand Ayurveda college |
| Address |
OPD NO.5 Department of panchakarma, Government Akhandanand Ayurveda Collage and Hospital, Bhadra.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9426404004 |
| Fax |
|
| Email |
vd.falgun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurveda Collage and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurveda college |
| Address |
Government Akhandanand Ayurveda college and Hospital, Bhadra,Ahmedabad |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ROMANA BARODIYA |
Government Akhandanand Ayurveda College And Hospital |
OPD NO.5, Department of panchakarma Akhandanand Ayurveda
Collage and Hospital, Bhadra
Ahmadabad
GUJARAT |
9978667431
romanabarodiya786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committe |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:M20-M25||Other joint disorders. Ayurveda Condition: AMAVATAJANYA SHOTHADI LAKSHANA W.S.R OF RHEUMATOID ARTHRITIS, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: cakrapani amavatjanya 26chap/1,2, Procedure details: 1.MATERIALS AND METHODS:
Sand -4 kg
Cotton cloth (45 cm X 45 cm) - 4
Tag- 4
Vessel (iron) - 1
Towel- 1
Attendents-2
2.PREPARATION OF POTTALI:
• Valuka pottali sweda:
- Clean sand, which is devoid of gravel and other waste materials, collect from a neat place will be used for this purpose.
-A vessel preferably iron will be placed on a stove and 4kg sand will be heated. Four pottali will be prepared.
- Each pottali has 250gm sand. Pottali will be reheat using remaining 3kg san)
| | 2 | Intervention Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: Caraka sutra sthan, Procedure details: 1.MATERIALS AND METHODS:
Samudra Lavana -4 kg
Cotton cloth (45 cm X 45 cm) - 4
Tag- 4
Vessel (iron) - 1
Towel- 1
Attendents-2
2.PREPARATION OF POTTALI:
• Lavana pottali sweda:
-A vessel preferably iron will be placed on a stove and four kg lavana will be heated. Four pottalies will be prepared. Each pottalies have 250gm sand. Pottali will be reheated using remaining 3kg Lavana.
3.PRE OPERATIVE PROCEDURE:
The patient will be seated on the droni with leg extended.
4.PROCEDU)
|
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with the classical signs and symptoms of AMAVATAJANYA SOTHADI LAKSHAN(Rheumatoid arthritis) will be taken into consideration like SANDHISHULA(Pain in joints),SANDHI STABDHTA(Stiffness in joints),SANDHI GUARVATA(Heaviness in joints),SAPARSHASHAYTA(Tenderness in joints) and SANDHI SHOTHA(Swelling in joints).
patients who are indicated for swedana. |
|
| ExclusionCriteria |
| Details |
Severe systemic diseases like cardiac disorders and carcinogenic condition, pregnant/lactating women, SWEDANA AYOGYA PATIENTS, Chronicity more than 10 years, PITTAJA PRAKRUTI And PITTAJA VIKARA, Gouty arthritis. |
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Find Improvement in signs & symptoms of Amavatajanya shothadi lakshana with the help of objective & subjective criteria.
Pain in joints
Stiffness in joints
Heaviness in joints
Tenderness in joints
Swelling in joints |
14days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Find Improvement in signs & symptoms of Amavatajanya shothadi lakshana with the help of scoring pattern, Assessment of RA-factor. |
4 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| Date of Study Completion (India) |
26/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/11/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In Allopathy
medical science, DMARDs and steroids are used to
manage pain in Aamvata. But these drugs
produce various side effects and also don’t completely eradicate or cure
the disease. So, Ayurveda has solution
to this current problem. Prevalence
of Rheumatoid Arthritis is 0.75% projected to the whole population of
India Thus, Rheumatoid arthritis is a serious problem and a
serious solution is needed to find out. So, this disease is selected for
research work. |